FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11977–12000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2022
AAMI4 Isolation Gown
K214116 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 285d
Cleared Oct 11, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L,...
K220169 · IYN
Bionet Co., Ltd.
Radiology · 264d
Cleared Oct 11, 2022
Apyx One Console
K221830 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 110d
Cleared Oct 11, 2022
Branchor Balloon Guide Catheter
K221951 · QJP
Asahi Intecc Co., Ltd.
Neurology · 98d
Cleared Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K222079 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 88d
Cleared Oct 11, 2022
ECHO Photocoagulator
K222157 · HQF
Norlase
Ophthalmic · 83d
Cleared Oct 11, 2022
Surgical Mask
K222335 · FXX
Luoyang Sunmed Devices Co., Ltd.
General Hospital · 69d
Cleared Oct 11, 2022
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
K222432 · OHT
Hunan Guangye Biotechnology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Oct 11, 2022
Renamel® Microhybrid
K222435 · EBF
Cosmedent, Inc.
Dental · 60d
Cleared Oct 11, 2022
Sol-M Luer Lock Syringe
K222744 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 29d
Cleared Oct 08, 2022
Disposable Vinyl Examination Gloves
K223008 · LYZ
Jiangxi Handspro Products Solutions...
General Hospital · 9d
Cleared Oct 07, 2022
Mico One Orthodontic Screw
K202163 · OAT
Ze Fang Technology Co., Ltd.
Dental · 795d
Cleared Oct 07, 2022
SuperCheck Pro Blood Glucose Monitoring System
K213061 · NBW
Ok Biotech Co., Ltd.
Chemistry · 380d
Cleared Oct 07, 2022
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper...
K213610 · GEI
Katalyst Surgical, LLC
General & Plastic Surgery · 326d
Cleared Oct 07, 2022
VisionAir Patient-Specific Airway Stent
K213969 · NWA
New Cos Inc. Dba Visionair Solutions
Anesthesiology · 291d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 274d
Cleared Oct 07, 2022
YADU Surgical Gowns
K220092 · FYA
Henan Yadu Industrial Co., Ltd.
General Hospital · 268d
Cleared Oct 07, 2022
RespiraSense
K220111 · BZQ
Pmd Solutions
Anesthesiology · 267d
Cleared Oct 07, 2022
Electrically Powered Wheelchair, Joy Rider
K220156 · ITI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 261d
Cleared Oct 07, 2022
MIM-Ablation
K220256 · QTZ
Mim Software, Inc.
Radiology · 249d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267 · FPA
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 07, 2022
BriefCase
K220709 · QAS
Aidoc Medical , Ltd.
Radiology · 211d
Cleared Oct 07, 2022
Infant Heel WarmerTM
K221154 · MPO
International Biomedical
Physical Medicine · 169d
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d